Kornimate/medical-research-clean huggingface dataset:
subcutaneous rehydration compared to intravenous rehydration

Conditions: Dehydration

Summary: randomized (1:1 ratio) study of subcutaneous (sc) versus intravenous (iv) fluid rehydration in mildly to moderately dehydrated pediatric patients.

this is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of sc versus iv fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the emergency department (ed), inpatient pediatric unit, and/or outpatient urgent care facility. it is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either sc administration with hylenex (150 units) or iv without hylenex.

Eligibility criteria:
inclusion criteria: * children of either gender from one month to ≤10 years of age. * patients with mild or moderate dehydration * healthy child except for the underlying etiology for dehydration * pre-dehydration body weight ≥ 5th percentile for age * parents or legal guardian(s) available to provide informed consent. exclusion criteria: * severe dehydration * shock or life-threatening situation (life expectancy \< 10 days). * requirement for iv access for any indication other than for treatment of dehydration. * indwelling iv catheter, except for one intended only for collection of clinical laboratory specimens. * any condition precluding sc infusion or infusion site evaluation * any reason (prior to study enrollment) for a hospital admission or an extended stay in the ed for other than dehydration. * known hypersensitivity to hyaluronidase or hylenex. * known hyponatremia (\ 155 meq/l). * known hypokalemia (\< 3.0 meq/l). * any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration. * participation in an investigational drug or device study within 30 days prior to enrollment in this study.

Keywords: pediatric hylenex subcutaneous infusion hyaluronidase rhuph20 recombinant human hyaluronidase
caudal corticosteroid vs. dextrose injection for lumbosacral radicular pain.

Conditions: no Conditions

Summary: study comparing caudal prolotherapy to conventional steroid for chronic low back pain


Eligibility criteria:
inclusion criteria 1. participants must satisfy diagnostic criteria for lumbar radicular pain at l4 nerve root level or below with consistent mri or x ray findings. 2. evidence of low back pain base upon one or more of the following: i. lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on vas. ii. has received at lest 2 types of ancillary treatment (i.e. physical therapy, oral analgesia, acupuncture, etc.) 3. men or women age greater than or equal to 18 years. 4. no significant alcohol use (7 or fewer drinks per week). 5. patient has a history of at least 2 failed epidural cs injections. exclusion criteria 1. treatment risk factors including one or more of the following: i. unstable or symptomatic cardiac complaints ii. unstable or symptomatic respiratory complaints iii. unable to reliably comprehend the protocol or reliably record data 2. pregnancy. a serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment. 3. history of malignancy 4. any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease, polyneuropathy) or psychosocial condition that in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
a study to assess the safety, pharmacokinetics, and tolerability of abi-1179 in healthy subjects and in subjects seropositive for hsv-2 with recurrent genital herpes

Conditions: Recurrent Genital Herpes Simplex Type 2

Summary: this study is designed to assess safety, tolerability, and pharmacokinetics (pk) of single ascending dose (sad) of abi-1179 in part a in healthy participants and multiple-ascending doses (mad) of abi-1179 in part b in participants seropositive for herpes simplex virus type 2 (hsv-2) with recurrent genital herpes. effect of food will also be evaluated in part a.


Eligibility criteria:
part a: inclusion criteria: * subject has a body mass index (bmi) between ≥18.0 and \<32.0 kg/m2 * in good health (as determined by the investigator) based on medical history, physical examination, ecg, and clinical laboratory results. * female subjects must be non-pregnant and have a negative serum pregnancy test at screening and a negative urine pregnancy test at day-1 or day 1 (predose). * agreement to comply with protocol-specified contraceptive requirements. part b: inclusion criteria: * subject has a body mass index (bmi) between ≥18.0 and \<32.0 kg/m2 * other than hsv infection, is in good health (as determined by the investigator) based on medical history, physical examination, ecg, and clinical laboratory results. * female subjects must be non-pregnant and have a negative serum pregnancy test at screening and a negative urine pregnancy test at day 1 (predose). * agreement to comply with protocol-specified contraceptive requirements part a and b: exclusion criteria: * current infection of human immunodeficiency virus (hiv), hepatitis b virus, (hbv), hepatitis c virus (hcv), acute hepatitis a virus (hav), or acute hepatitis e virus (hev). * history of any illness that, in the opinion of the investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs. * history of any significant drug-related allergic reactions such as anaphylaxis, stevens-johnson syndrome, urticaria, or multiple drug allergies. * history of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening. * has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.

Keywords: abi-1179, pk, healthy participants, hsv-2, recurrent genital herpes
nac in preventing cin in crf patients who need enhanced ct scan in ed

Conditions: Chronic Renal Failure

Summary: the purpose of this study is to evaluate the effect of nac or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

cin is frequent in crf patients. however most studies about cin has been focusing on elective pci patients. there is no study that the nac nor sodium bicarbonate would help in preventing cin in crf patients who need enhanced ct scan in ed. our intention was to investigate the effect of nac or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Eligibility criteria:
inclusion criteria: * crf patients who need enhanced ct scan exclusion criteria: * less than 15 years old * hypersensitivity to nac * on dialysis * no consent from patient or next of kin

Keywords: n-acetylcysteine nephropathy bicarbonate
a study of the safety and efficacy of infliximab (remicade) in pediatric patients with crohn's disease

Conditions: Crohn Disease

Summary: a study of the safety and efficacy of infliximab (remicade) in pediatric patients with moderate to severe crohn's disease

this is a medical research study to evaluate the safety and effectiveness of an antibody called infliximab (remicade) in the treatment of children with crohn's disease. in this study, subjects will receive multiple doses of infliximab over 62 weeks. the goal of the study is to ensure that the medication is safe and effective in children when it is given for an extended period of time. all subjects will receive an induction regimen of 5 mg/kg infliximab at weeks 0, 2, and 6. subjects will then receive either 5 or 10 mg/kg infliximab either every 8 or 12 weeks for up to 46 weeks followed by an open label extension for up to three additional years.

Eligibility criteria:
inclusion criteria: * between the ages of 6 and 17 years * have had crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy * have active crohn's disease despite adequate current treatment with an immunomodulator (ie, aza, 6-mp, or mtx). exclusion criteria: * disease complications for which surgery might be indicated * surgery for bowel diversion with placement of a stoma within 3 months prior to screening * positive stool examination for enteric pathogens including giardia lamblia, clostridium difficile, shigella species, and salmonella species.

Keywords: crohn's disease pediatric crohn's disease
supervised group-based walking intervention among inactive older adults in saudi arabia

Conditions: Physical Activity

Summary: the purpose of the proposed study is to compare the effects of supervised group-based walking and non-supervised individual-based walking interventions on frailty, cognitive function and quality of life among inactive older adults in saudi arabia.

objectives 1. to compare the difference of effects between supervised group-based walking and non-supervised individual-based walking on the primary outcomes, including frailty, cognitive functions, and health-related quality of life among inactive older adults in saudi arabia. 2. to compare the difference of effects between supervised group-based walking and non-supervised individual-based walking on the secondary outcomes, including physical activity enjoyment, health parameters consisting of resting heart rate, resting blood pressure, and body composition, as well as walking performance among inactive older adults in saudi arabia. 3. to formulate guidelines for achieving an effective walking intervention for inactive older adults in saudi arabia. 4. to recommend the government of saudi arabia on guidelines and policies for promoting walking and active ageing among the older adults in the country.

Eligibility criteria:
inclusion criteria: * 60-70 years old * capable of walking without assistive device * healthy and live independently in communities * being physically inactive exclusion criteria: * with cardiovascular or related diseases that prevent from intensive walking * fail the par-q screening or without physician's advice on readiness of participation in exercise training * diagnosed with cognitive impairment

Keywords: ageing older adults physical activity group-based intervention quality of life
soy isoflavones supplementation in treating women at high risk for or with breast cancer

Conditions: BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming. the use of soy isoflavones supplements may prevent or treat early stage breast cancer. purpose: this clinical trial studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.

primary objectives: i. to assess whether magnetic resonance imaging (mri) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive breast cancer or dcis who are supplemented daily with soy (5p mg total isoflavones as aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.ii. to assess whether cell proliferation and apoptosis, as measured by ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.secondary objectives: i. to assess whether other intermediate molecular markers including estrogen receptor alpha (er alpha) and er beta differ between women supplemented with soy vs placebo. outline: patients are randomized to 1 of 2 treatment arms.arm i: patients receive oral soy isoflavones supplement once daily for12 months in the absence of disease progression.arm ii: patients receive oral placebo once daily for 12 months in the absence of disease progression.

Eligibility criteria:
inclusion criteria: * women at high risk for breast cancer, defined as any of the following groups: * five year gail risk \> 1.7% * known brca1/brca2 mutation carrier * family history consistent with hereditary breast cancer * prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (lcis) * history of invasive breast cancer or ductal carcinoma in situ (dcis) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor * signed informed consent exclusion criteria: * metastatic breast cancer * undergoing treatment (chemotherapy, radiation, or serms) * pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry * regular soy consumers (i.e., \< once per week of soy food, soy supplements or other products) * known food allergies such as to soy or nuts * not willing to avoid soy foods/supplements during study period * current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study * cannot stop taking aspirin or nsaids within a week of breast biopsy * active participant in other ongoing trials
effects of nigella sativa on t cells and cytokine profile in pediatric sle patients

Conditions: SLE (Systemic Lupus)

Summary: the goal of this clinical trial is to learn if nigella sativa oil works to improve sledai score in sle pediatric student. it will also learn about the treg, t helper cells, and cytokine of the patient. the main questions it aims to answer are: does nigella sativa oil lower the sledai score in pediatric patient? how does the effects of nigella sativa oil on treg cells, t helper cells, and cytokine in pediatric patient? researchers will compare nigella sativa oil group to a placebo group (a look-alike substance that contains no drug) to see if nigella sativa oil works to treat sle in pediatric patients. participants will: visit the clinic once in the beginning for pre treatment checkups. take nigella sativa oil or a placebo every day for 8 weeks. visit the clinic once every 4 weeks for checkups. visit the clinic after 8 weeks for post treatment checkups.

sle in paediatric patients requires long-term treatment with several side effects. nigella sativa is known to have immunomodulatory effects. our study aimed to investigate the immune-modulatory effects of nigella sativa oil on t lymphocyte activity, inflammatory cytokine profile, and improvement of sledai score in our patients. this was a placebo-controlled clinical trial of nigella sativa oil administration in 32 paediatric sle patients who were tested before and after treatment. the study subjects were randomly assigned. patients had blood samples taken to be tested for t cell ratio, percentage of a number of cytokines (ifn-γ, tnf-α, il-2, il-4, il-6, il-17, and il-10) using flow cytometry and cba (cytometric bead array), and sledai score at the beginning of the study and after treatment. they were treated with 1 gram of n. sativa oil capsules and 1 gram of placebo daily for 8 weeks.

Eligibility criteria:
inclusion criteria: * pediatric sle patients aging between 1 and 18 years old according to the 2010 acr-eular criteria * being under treatment with prednisone, hydroxychloroquine, and mycophenolic acid * not receiving any biological agent or cytokine inhibitors for at least 2 months prior to the intervention exclusion criteria: * patients with any metabolic disorders (diabetes mellitus, cushing's syndrome, and thyroid dysfunctions), any kidney or liver diseases, chronic inflammatory diseases (including inflammatory bowel diseases), * patients with history of taking antioxidant or anti-inflammatory supplements 2 months prior to the interventions

Keywords: immunomodulator t lymphocyte inflammatory cytokine
combined use of respiratory devices after thoracic surgery

Conditions: Dyspnea; Well Being

Summary: in a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. new devices called respilift® and respivol® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. the aim of the investigators study is to test the clinical efficacy of respilift® and respivol® in patients with a recent history of cardio-thoracic surgery.


Eligibility criteria:
inclusion criteria: * \> 18 years old * recent cardio-thoracic surgery (\< 30 days of admission) * compliance to pulmonary rehabilitation program exclusion criteria: * clinical instability * concomitant severe co-morbidities * inability to use respiratory devices

Keywords: cardio-thoracic surgery patients pulmonary volume respiratory muscle performance
prevention of maternal hypotension during elective caesarean section performed with spinal anaesthesia, through intermittent pneumatic compression system in the lower extremities

Conditions: Hypotension

Summary: the hypotension defined as 20 % less than the basal sbp (systolic blood pressure)and / or an absolute value \<90-100 mmhg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby. the purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.


Eligibility criteria:
inclusion criteria: * pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. inform consent signed. exclusion criteria: * caesarean section urgent / emergent * caesarean section with epidural anaesthesia * caesarean section of multiple pregnancies * obstetric pathology: preeclampsia, eclampsia, hellp syndrome (hemolysis elevated liver enzymes low platelet count), small for gestational age (sga), preterm (\<32 weeks) * valvular heart disease and / or ischemic * high blood pressure diagnosed and in treatment. * sepsis * morbid obesity (bmi\> 40) * insulin-dependent diabetes * block level achieved with spinal anaesthesia\> t5 * patients that can not meet the study protocol

Keywords: caesarean hypotension spinal anaesthesia intermittent pneumatic compression lower extremities
diet, exercise and vitamin d in breast cancer recurrence

Conditions: Breast Cancer

Summary: the purpose of this study is to reduce breast cancer recurrence and hence increase disease-free survival through a lifestyle program that includes a low glycemic diet, physical activity and vitamin d supplementation in women with breast cancer living in a mediterranean country.

the aim of this study is to reduce breast cancer recurrence and hence increase disease-free survival through either a high intensity or a lower intensity lifestyle program that includes low glycemic index diet, physical activity and supplementation with vitamin d, for 33 months, in women living in italy who have been surgically treated for breast cancer (either late stage or early stage but highly proliferative) within the previous 12 months. the objectives of the study are: to determine if the high intensity program is more efficacious than the lower intensity program in: 1) reducing breast cancer recurrence and 2) improving glycemic, hormonal, cardiovascular and cancer-related epigenetic markers.

Eligibility criteria:
inclusion criteria: 1. women with primary diagnosis of histologically confirmed breast cancer (t1 with ki67≥30%, t2, t3 without metastasis) within 12 months from diagnosis. 2. age ≥ 30 and \< 75 years. 3. patients who are able to comprehend and are willing to sign the consent form and are able to adhere to the protocol including scheduled clinic visits and assigned treatment. exclusion criteria: 1. patients who do not possess the inclusion criteria for this study. 2. patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (ca\>11mg/dl). 3. patients with any previous or current concomitant other malignant cancer. 4. pregnant or lactating women. 5. patients with aids diagnosis 6. patients with severe renal insufficiency 7. patients with kidney stones (nephrocalcinosis or nephrolithiasis) 8. patients participating in other lifestyle clinical trials

Keywords: lifestyle low glycemic index diet exercise vitamin d breast cancer mediterranean diet
a trial of an audit and feedback report to improve colonoscopy performance

Conditions: Colorectal Polyps

Summary: this project aims to measure the impact of a physician report card (also called an audit \& feedback report) on colonoscopy performance. endoscopists in ontario will be randomly assigned to either receive the endoscopist report card or to no feedback. using ontario health administrative data, the quality of colonoscopy will be compared between those who received the report card and those who do not. the investigators will also measure the effect of receiving endoscopist report card on colonoscopy performance amongst endoscopists who perform poorly at baseline compared to those who do not. further, the acceptability of two educational interventions that aim to improve the quality of colonoscopy will be evaluated by conducting one-on-one interviews with select participants. this study is critical to ensure that canadians have access to the highest quality colonoscopy possible.


Eligibility criteria:
inclusion criteria: * all practising endoscopists in ontario who performed at least 5 colonoscopies in 2014 exclusion criteria: -

Keywords: endoscopy measures audit and feedback quality improvement randomized controlled trial colonoscopy
perioperative folfiri vs adjuvant folfiri in resectable advanced crc failed to oxaliplatin

Conditions: Colorectal Neoplasms; Effects of Chemotherapy; Surgery; Metastasis; Local Neoplasm Recurrence

Summary: colorectal cancer (crc) is one of the most leading causes of cancer death in china. although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced crc still remains poor. while around 30% of resectable advanced crc could be cured. this study is designed to compare perioperative folfiri versus adjuvant folfiri in resectable advanced crc who exposed to oxaliplatin in open-label, phase iii mode.


Eligibility criteria:
inclusion criteria: * age:18-80 * ecog score: 0 or 1 * histological confirmed of colorectal adenocarcinoma * history of exposure to oxaliplatin * with local recurrent or metastatic focus * tumor resectable confirmed by at less 3 hepatobiliary surgeon * informed content acquired exclusion criteria: * history of exposure to irinotecan * received surgery in recently 4 weeks or did not recover from surgery * other history of cancer in recent 5 years * fluorouracil allergy or dihydropyrimidine dehydrogenase defect * women with potential pregnancy.